Peptide profile

Sermorelin: FDA Status, Research and Uses

By Living+. Updated October 25, 2026.

Key takeaway

Sermorelin is a lab-made 29 amino acid analog of growth hormone-releasing hormone (GHRH). FDA approved it as Geref in 1990 and 1997. The maker stopped selling it in 2008, and in 2013 FDA found this was not for safety or effectiveness reasons. It was studied for growth hormone deficiency in children ^{[1, 4, 5]}.

At a glance

Where it stands

Checked November 2, 2026

FDA approvedNoNo approved product
Pharmacy compounding (503A)AllowedNot in any 503A category on FDA's list updated May 14, 2026. FDA's 503B list marks sermorelin acetate as a component of an FDA-approved drug (Geref, discontinued). FDA found in 2013 that Geref was not withdrawn for safety or effectiveness reasons. FDA has not said how the 2009 withdrawal of Geref affects 503A compounding
Outsourcing facilities (503B)Under reviewSermorelin acetate is in 503B category 1, marked as a component of an FDA-approved drug (list updated March 21, 2025).
WADA (sport)ProhibitedS2.2.4 Growth hormone releasing factors (GHRH analog)

Same data as the Status Tracker. Checked against 8 sources

Key facts

Class: Growth hormone-releasing hormone (GHRH) analog ^[4]
Length: 29 amino acids ^[4]
Half-life: About 4.3 minutes after IV infusion of GHRH 1-29 (one study, 10 healthy men) ^[7]
Route in studies: Intravenous (diagnostic test) and subcutaneous (daily use) ^[4]
First studied: GHRH was isolated in 1982; Geref was first FDA approved in 1990 ^{[11, 2]}

How it works

The brain makes a hormone called growth hormone-releasing hormone, or GHRH. GHRH signals the pituitary gland to release growth hormone. Sermorelin is a lab-made peptide that matches the first 29 amino acids of human GHRH. It is the shortest synthetic piece with the full activity of GHRH ^[4].

Given by vein or under the skin, sermorelin acts on the front part of the pituitary gland and causes it to release growth hormone ^[4]. Because of this, it only raises growth hormone when the pituitary can still respond. FDA notes that Geref was approved only for a select group of children with idiopathic growth hormone deficiency who responded to a Geref stimulation test ^[12].

Sermorelin leaves the blood fast. In 10 healthy men given an IV infusion of GHRH 1-29, the disappearance half-time was about 4.3 minutes. A version with one changed amino acid lasted about 6.7 minutes ^[7].

In older men, nightly doses for 6 weeks raised growth hormone release at night. IGF-1 levels did not change in that study ^[6].

Sermorelin belongs to the same family as tesamorelin and CJC-1295. The WADA Prohibited List names all three as GHRH analogs ^[8].

What the research shows

3 human trials

1997Human trial
Vittone et al., older men
11 healthy men aged 64 to 76 Single group, before and after, 6 weeks of nightly GHRH 1-29
Nighttime growth hormone release rose. IGF-1, weight and body fat did not change. 2 of 6 strength measures changed ^[6]
Read the study
1996Human trial
Geref International Study Group (Thorner et al.)
110 children with growth hormone deficiency (86 analyzed for efficacy) Multicenter, open label, up to 1 year
Mean height velocity rose from 4.1 cm/yr at baseline to 8.0 cm/yr at 6 months and 7.2 cm/yr at 12 months on 30 mcg/kg once daily at bedtime ^[5]
Read the study
1994Human trial
Soule et al., clearance study
10 healthy men IV infusion of two GHRH 1-29 forms
GHRH 1-29 had a disappearance half-time of 4.3 minutes; the D-Ala2 form lasted 6.7 minutes ^[7]
Read the study

Doses used in studies

In the Geref study of children with growth hormone deficiency, the dose was 30 mcg/kg given subcutaneously once daily at bedtime ^[5]. For diagnostic testing, a single IV dose of 1 mcg/kg was used ^[4].

In a 6-week study of healthy older men, the dose was 2 mg given subcutaneously each night ^[6].

Dosing is set by a licensed provider.

Side effects and safety

In a review of the Geref data, single IV doses and repeated daily subcutaneous doses were well tolerated. Brief facial flushing and pain at the injection site were the most common side effects ^[4]. In the 1-year study in children, no harmful changes were seen in blood tests, fasting glucose or IGF-1 ^[5].

In 2013 FDA reviewed its files and postmarketing adverse event data. It found that neither Geref product was withdrawn from sale for reasons of safety or effectiveness ^[1]. Drugs@FDA lists both Geref products as discontinued, so no FDA-approved sermorelin product is sold today ^{[2, 3]}.

Legal and regulatory history

May 14, 2026
FDA's 503A nominations list, updated May 14, 2026, does not list sermorelin in category 1, 2 or 3 ^[10]. Source
January 1, 2026
The WADA 2026 Prohibited List took effect. It names sermorelin under S2.2.4 (GHRH and its analogs), banned at all times ^[8]. Source
March 21, 2025
FDA's 503B list, updated March 21, 2025, places sermorelin acetate in category 1 (under evaluation) and marks it as a component of an FDA-approved drug ^[9]. Source
March 4, 2013
FDA published its finding that both Geref products were not withdrawn from sale for reasons of safety or effectiveness. This lets FDA approve generic (ANDA) versions that meet all other rules ^[1]. Source
June 18, 2009
FDA withdrawal of approval of NDA 19-863 and NDA 20-443 took effect, after the maker asked for it (74 FR 23407) ^[1]. Source
December 2, 2008
EMD Serono told FDA that the Geref 0.5 mg and 1.0 mg vials were being discontinued. It had sent a similar letter for the 0.05 mg ampule on July 11, 2008 ^[1]. Source
September 26, 1997
FDA approved Geref vials (NDA 20-443) to treat idiopathic growth hormone deficiency in children with growth failure ^{[1, 3]}. Source
December 28, 1990
FDA approved the Geref 0.05 mg ampule (NDA 19-863) as a test of the pituitary's ability to release growth hormone ^{[1, 2]}. Source

Common questions

Is sermorelin FDA approved?

Not today. FDA approved Geref (sermorelin acetate) in 1990 and 1997. The products were discontinued in 2008, and FDA withdrew the approvals in 2009 at the maker's request ^[1].

Why was sermorelin discontinued?

The maker, EMD Serono, told FDA in 2008 that it was discontinuing Geref. In 2013 FDA found it was not withdrawn from sale for reasons of safety or effectiveness. The FDA notice does not give the maker's business reason ^[1].

Can a generic sermorelin be approved?

Yes, in principle. FDA's 2013 finding allows it to approve generic (ANDA) versions that refer to Geref, as long as they meet all other legal rules ^[1].

Can pharmacies compound sermorelin?

FDA's 503B list places sermorelin acetate in category 1 and marks it as a component of an FDA-approved drug ^[9]. It is not in any 503A category ^[10]. Compounded sermorelin is not FDA approved.

Is sermorelin banned in sports?

Yes. The WADA 2026 Prohibited List names sermorelin under S2.2.4, banned in and out of competition ^[8].

Is sermorelin the same as growth hormone?

No. Sermorelin is a 29 amino acid GHRH analog. It signals the pituitary to release the body's own growth hormone ^[4].

What side effects were seen with sermorelin?

In the Geref data, brief facial flushing and injection site pain were the most common side effects ^[4].

How is sermorelin different from tesamorelin and CJC-1295?

All three are GHRH analogs, and WADA lists them together under S2.2.4 ^[8]. Sermorelin is the short 29 amino acid form that was once approved as Geref ^{[4, 1]}.